Method of fabricating an elongate medical device

ABSTRACT

An elongate medical device having an axis comprises an inner liner, a jacket radially outward of the liner, a braid comprising metal embedded in the jacket, a sensor, and at least one wire electrically connected to said sensor. The at least one wire is one of: embedded in the jacket and optionally disposed helically around the braid; extending longitudinally within a tube which extends generally parallel to the device axis and wherein the tube is embedded in the jacket; and disposed within a lumen, wherein the lumen extends longitudinally within the jacket.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 14/159,007, filed 20 Jan. 2014, issued as U.S. Pat. No. 9,457,167 on 4 Oct. 2016, which is a continuation of U.S. application Ser. No. 12/981,963, filed 30 Dec. 2010, issued as U.S. Pat. No. 8,636,718, on 28 Jan. 2014, both of which are hereby incorporated by reference as though fully set forth herein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

The present disclosure relates to a method of manufacturing a catheter or other elongate medical device to reduce the stress induced on an electrical cable in the catheter or other elongate medical device.

b. Background Art

Many medical procedures require the introduction of specialized medical devices into and/or around the human heart. In particular, there are a number of medical procedures that require the introduction of specialized devices including, but not limited to, catheters, dilators, and needles to areas, such as into the atria or ventricles to access the inner surface of the heart, or into the pericardial sac surrounding the heart to access the epicardial or outer surface of the heart. Catheters, guidewires, and access sheaths or introducers have been used for medical procedures for a number of years.

It is typically necessary for introducers, guidewires, and catheters to exhibit a balance of flexibility and rigidity to be able to maneuver through the vasculature of a patient during the performance of medical procedures. In addition, it is desirable to reduce the stress induced on a catheter, introducer, or other elongate medical device during bending. In particular, it is desirable to reduce the stress induced on electrical wiring by bending of the medical device, as such stress may interrupt the functionality of sensors attached to such wiring.

There is therefore a need for a MPS-enabled elongate medical device and methods of manufacture thereof that minimize or eliminate one or more of the problems set forth above.

BRIEF SUMMARY OF THE INVENTION

One advantage of the methods and apparatus described, depicted, and claimed herein relates to a reduction in the stress experienced in or by wiring in a medical device that connects a positioning sensor (e.g., at a distal end) to a connector (e.g., at a proximal end) when the device is subjected to bending or deflection.

This disclosure is directed to an elongate medical device configured for use with a positioning system (i.e., the device includes a positioning sensor). The device has an axis and includes an inner liner, a jacket radially outward of the liner, a braid comprising metal embedded in the jacket, a sensor, and at least one wire electrically connected to the sensor. The at least one wire is incorporated in the device in at least one of the following ways: (i) the at least one wire is embedded in the jacket and may optionally be disposed helically about the braid; (ii) the at least one wire extends longitudinally within a tube which is embedded in the jacket; and (iii) the at least one wire is disposed within a lumen where the lumen extends longitudinally within the jacket. Through the foregoing, the stress experienced by the at least one wire, for example when the device is subjected to bending, is reduced, which in turn reduces the occurrence of breaks or the like either in the wire or at the connection node where the wire is connected to the sensor.

In another aspect, a method of fabricating an elongate medical device having an axis comprises the steps of providing an elongate liner having a distal end and a proximal end, surrounding the liner with a braid comprising metal, placing a positioning sensor over the braid at the distal end, disposing a longitudinally-extending element radially outward from the braid such that the element is generally parallel to the axis, applying an outer layer over the braid, the sensor, and the longitudinally-extending element, and subjecting the device to a reflow lamination process.

These and other benefits, features, and capabilities are provided according to the structures, systems, and methods depicted, described and claimed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic and block diagram view of a system incorporating an embodiment of an MPS-enabled elongate medical device.

FIG. 2 is a diagrammatic view of the system of FIG. 1 in a catheter-lab environment.

FIGS. 3-8 are isometric side views of a reflow mandrel assembly in various stages of build-up in a method of manufacture of a first embodiment and a second embodiment of an MPS-enabled elongate medical device.

FIG. 9 is an isometric view of a third embodiment of an MPS-enabled elongate medical device at a stage of construction equivalent to that shown in FIG. 7.

FIG. 10 is a cross-sectional view of an MPS-enabled elongate medical device, before a reflow lamination process, taken substantially along line 10-10 in FIG. 8.

FIG. 11 is the cross-sectional view of FIG. 10, after a reflow lamination process.

FIG. 12a is an expanded view of a portion of the cross-section of FIG. 11, illustrating the first embodiment of an MPS-enabled elongate medical device.

FIG. 12b is an expanded view of a portion of the cross-section of FIG. 11, illustrating the second embodiment of an MPS-enabled elongate medical device.

FIG. 12c is an expanded view of a portion of the cross-section of FIG. 11, illustrating the third embodiment of an MPS-enabled elongate medical device.

FIG. 13 is an isometric view of a fourth embodiment of an MPS-enabled elongate medical device.

FIG. 14 is a cross-sectional view of the fourth embodiment, taken substantially along line 14-14 in FIG. 13.

FIG. 15 is a diagrammatic view of a fifth embodiment of an MPS-enabled elongate medical device.

FIG. 16 is a schematic and block diagram view of one exemplary embodiment of a medical positioning system (MPS) as shown in block form in FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings wherein like reference numerals are used to identify identical components in the various views, FIG. 1 is a diagrammatic view of a system 10 in which a position sensing elongate medical device such as a guidewire or catheter may be used. It should be understood that while embodiments will be described in connection with a magnetic field-based positioning system in a catheter-lab environment, this is exemplary only and not limiting in nature.

There is a desire to reduce a patient's exposure to x-rays, such as may be used in live fluoroscopy, at least for the purpose of navigating a medical device such as a catheter within the patient's body. Such a desire may be met by providing a medical device that includes a positioning sensor configured to cooperate with an external (i.e., external to the patient's body) positioning system that can determine the position of the device in three-dimensional space. With this position information, a navigation system can superimpose a representation of the medical device over a previously-obtained image (or series of images) of the region of interest in the patient's body. Accordingly, the clinician may use the superimposed imaging for navigation purposes rather than full time fluoroscopy. Thus, through the provision of a medical device with position sensing capability, the use of fluoroscopy may be reduced significantly (and the accompany X-ray exposure for the patient). The methods and apparatus described herein relating to medical positioning system (MPS)-enabled medical devices facilitate the reduction of the need for continuous exposure or extensive use of fluoroscopy for such purposes.

With continued reference to FIG. 1, system 10 as depicted includes a main electronic control unit 12 (e.g., one or more processors) having various input/output mechanisms 14, a display 16, an optional image database 18, a localization system such as a medical positioning system (MPS) 20, an electrocardiogram (ECG) monitor 22, one or more MPS location sensors respectively designated 24 ₁ and 24 ₂ (i.e., shown as a patient reference sensor), and an MPS-enabled elongate medical device 26 which itself includes one or more of the above-described MPS location sensors, shown in exemplary fashion as having one such sensors 24 ₁.

Input/output mechanisms 14 may comprise conventional apparatus for interfacing with a computer-based control unit, for example, a keyboard, a mouse, a tablet, a foot pedal, a switch or the like. Display 16 may also comprise conventional apparatus.

Embodiments consistent with the invention may find use in navigation applications that use imaging of a region of interest. Therefore system 10 may optionally include image database 18. Image database 18 may be configured to store image information relating to the patient's body, for example a region of interest surrounding a destination site for medical device 26 and/or multiple regions of interest along a navigation path contemplated to be traversed by device 26 to reach the destination site. The image data in database 18 may comprise known image types including (1) one or more two-dimensional still images acquired at respective, individual times in the past; (2) a plurality of related two-dimensional images obtained in real-time from an image acquisition device (e.g., fluoroscopic images from an x-ray imaging apparatus, such as that shown in exemplary fashion in FIG. 2) wherein the image database acts as a buffer (live fluoroscopy); and/or (3) a sequence of related two-dimensional images defining a cine-loop (CL) wherein each image in the sequence has at least an ECG timing parameter associated therewith adequate to allow playback of the sequence in accordance with acquired real-time ECG signals obtained from ECG monitor 22. It should be understood that the foregoing are examples only and not limiting in nature. For example, the image database may also include three-dimensional image data as well. It should be further understood that the images may be acquired through any imaging modality, now known or hereafter developed, for example X-ray, ultra-sound, computerized tomography, nuclear magnetic resonance or the like.

MPS 20 is configured to serve as the localization system and therefore to determine positioning (localization) data with respect to one or more of MPS location sensors 24 _(i) (where i=1 to n) and output a respective location reading. The location readings may each include at least one or both of a position and an orientation (P&O) relative to a reference coordinate system, which may be the coordinate system of MPS 20. For example, the P&O may be expressed as a position (i.e., a coordinate in three axes X, Y and Z) and orientation (i.e., an azimuth and elevation) of a magnetic field sensor in a magnetic field relative to a magnetic field generator(s) or transmitter(s).

MPS 20 determines respective locations (i.e., P&O) in the reference coordinate system based on capturing and processing signals received from the magnetic field sensors 24 _(i) while such sensors are disposed in a controlled low-strength AC magnetic field (see FIG. 2). From an electromagnetic perspective, these sensors develop a voltage that is induced on the coil residing in a changing magnetic field, as contemplated here. Sensors 24 _(i) are thus configured to detect one or more characteristics of the magnetic field(s) in which they are disposed and generate an indicative signal, which is further processed by MPS 20 to obtain a respective P&O thereof. Exemplary design features and manufacturing processes and methods for sensors 24 _(i) and medical devices incorporating such sensors will be described in greater detail below in conjunction with FIGS. 3-12.

MPS sensor 24 ₁, and optionally additional MPS sensors in further embodiments, may be associated with MPS-enabled medical device 26. Another MPS sensor, namely, patient reference sensor (PRS) 24 ₂ (if provided in system 10) is configured to provide a positional reference of the patient's body so as to allow motion compensation for gross patient body movements and/or respiration-induced movements. PRS 24 ₂ may be attached to the patient's manubrium sternum, a stable place on the chest, or another location that is relatively positionally stable. Like MPS location sensor 24 ₁, PRS 24 ₂ is configured to detect one or more characteristics of the magnetic field in which it is disposed wherein MPS 20 provides a location reading (e.g., a P&O reading) indicative of the PRS's position and orientation in the reference coordinate system.

The electro-cardiogram (ECG) monitor 22 is configured to continuously detect an electrical timing signal of the heart organ through the use of a plurality of ECG electrodes (not shown), which may be externally-affixed to the outside of a patient's body. The timing signal generally corresponds to the particular phase of the cardiac cycle, among other things. Generally, the ECG signal(s) may be used by the control unit 12 for ECG synchronized play-back of a previously captured sequence of images (cine loop) stored in database 18. ECG monitor 22 and ECG-electrodes may both comprise conventional components.

FIG. 2 is a diagrammatic view of system 10 as incorporated into an exemplary catheter laboratory. System 10 is shown as being incorporated into a fluoroscopic imaging system 28, which may include commercially available fluoroscopic imaging components (i.e., “Catheter Lab”). MPS 20 includes a magnetic transmitter assembly (MTA) 30 and a magnetic processing core 32 for determining location (P&O) readings. MTA 30 is configured to generate the magnetic field(s) in and around the patient's chest cavity, in a predefined three-dimensional space identified as a motion box 34. MPS sensors 24 _(i) as described above are configured to sense one or more characteristics of the magnetic field(s) and when the sensors are in motion box 34, each generate a respective signal that is provided to magnetic processing core 32. Processing core 32 is responsive to these detected signals and is configured to calculate respective P&O readings for each MPS sensor 24 _(i) in motion box 34. Thus, MPS 20 enables real-time tracking of each sensor 24 _(i) in three-dimensional space.

The positional relationship between the image coordinate system and the MPS reference coordinate system may be calculated based on a known optical-magnetic calibration of the system (e.g., established during setup), since the positioning system and imaging system may be considered fixed relative to each other in such an embodiment. However, for other embodiments using other imaging modalities, including embodiments where the image data is acquired at an earlier time and then imported from an external source (e.g., imaging data stored in database 18), a registration step registering the MPS coordinate system and the image coordinate system may need to be performed so that MPS location readings can be properly coordinated with any particular image being used. One exemplary embodiment of an MPS 20 will be described in greater detail below in connection with FIG. 16.

For an MPS-enabled medical device 26, such as a catheter, to be tracked by a localization system such as MPS 20, electrical function of MPS sensors coupled with the device must be assured. As such, signal and power wiring associated with such sensors should be assembled in the medical device with a method that minimizes the stress induced on the wiring by bending of the medical device.

FIGS. 3-8 are isometric, exaggerated side views of a reflow mandrel assembly in various stages of build-up in a method of manufacture of a first embodiment and a second embodiment of an MPS-enabled elongate medical device 26. It should be understood that while radial “gaps” or clearances are shown in FIGS. 3-8 between the several layers of materials, this is done for clarity only to distinguish the separate layers.

FIG. 3 shows a mandrel 36 having a distal end portion 38 and a proximal end portion 40. Mandrel 36 may be circular in radial cross-section and have a desired length, in view of the elongate medical device to be made.

As shown in FIG. 4, an elongate inner liner 42 may then be placed on the mandrel 36. Once installed on the mandrel 36, inner liner 42 may be secured, for example, by knotting one or both ends. Inner liner may comprise polymeric materials, or may comprise polytetrafluoroethylene (PTFE).

As shown in FIG. 5, the next step may involve placing a sheath layer, such as a braid layer 44, over inner liner 42 to surround inner liner 42. Braid layer 44 may comprise conventional materials and construction approaches, such as, for example only, metal braid (e.g., 0.002″ thick×0.006″ wide wire woven in accordance with a known braid pattern), such as stainless steel. Braided wire in braid layer 44 may be rounded wire, flat wire with a rectangular cross-section (i.e., taken along a plane orthogonal to axis “A”), or another appropriate wire known in the art.

Sensor 24 ₁ may then be placed over braid layer 44 on or at distal end portion 38, as shown in FIG. 6. Sensor 24 ₁ may be a coil sensor, including a tubular core and a wire coil wrapped on the core, or another suitable sensor known in the art. As shown, coil sensor 24 ₁ includes a pair of free ends 45 ₁ and 45 ₂.

A longitudinally-extending element 46 may then be placed over braid layer 44, as shown in FIG. 7. Longitudinally-extending element 46 may extend from proximal end portion 40 to the proximal end of sensor 24 ₁ and as described below is used to establish a path or conduit through an outer polymer layer (shown in FIG. 8) for one or more signal wires and/or one or more power wires in the finished medical device.

The construction of element 46 will vary between the first and second embodiments. In the first embodiment of the medical device, designated device 26 a (best shown in FIG. 12a ), longitudinally-extending element 46 is a tube configured to remain in place in the finished assembly. The tube includes a central passage through which connecting wires may be passed from the proximal end 40 of the device for electrical coupling to sensor 24 ₁. In the second embodiment of the medical device, designated device 26 b (best shown in FIG. 12b ), longitudinally-extending element 46 is an elongate solid body configured to be removed from the outer layer of the finished assembly. Removal of the elongate solid body leaves a corresponding lumen extending longitudinally through the outer layer (jacket) and through which the connecting wires may be threaded from the proximal end 40 to be electrically coupled to sensor 24 ₁. Such an elongate solid body may comprise, for example, but without limitation, a pin coated with PTFE. The pin is removed from proximal end 40 of finished device 26.

In any of the embodiments of device 26, the wiring 50 referred to herein for connecting to sensor 24 ₁ may comprise an unshielded twisted-pair (TP) cable or alternately a shielded twisted-pair cable, or any other functionally equivalent signal or power cable known in the art comprising at least one wire. One or more of polymer, PTFE, and/or other appropriate materials may be included in wiring 50 for electrical insulation.

As shown in FIG. 8, an outer layer 48 is then applied over the sub-assembly thus formed. Outer layer 48 may comprise conventional melt processing polymers, such as, for example only, an elastomer commercially available under the trade designation PEBAX® from Arkema, Inc. Furthermore, outer layer 48 may comprise either a single section or multiple sections of tubing that are either butted together or overlapped with each other. The multiple segments, or layers, of outer layer material may be any length and/or hardness (durometer) allowing for flexibility of design, as known in the art. The distal end portion and proximal end portions of the device may be uncovered by outer layer 48. Free ends 45 ₁, 45 ₂ may be secured so as to not become embedded in outer layer 48. The distal end of element 46 is secured or protected so as to not receive melted (and thus fluid) melt polymer of outer layer 48. In an embodiment, a removable stop may be used.

The assembly thus formed is then subjected to a reflow lamination process, which involves heating the assembly until the outer layer material flows and redistributes around the circumference, covering and embedding braid layer 44, sensor 24 ₁, and longitudinally-extending element 46. In one embodiment, the reflow process includes heating the device to about 450° F. (e.g., in an oven-like appliance), though the reflow temperature may vary for other embodiments of the method. Device 26 is then cooled. After cooling, outer layer 48 may be a unitary jacket 48. The distal and proximal end portions of device 26 may then be finished in a desired fashion. It should be understood that as used with reference to a medical device herein, “distal” refers to an end that is advanced to the region of interest within a body while “proximal” refers to the opposite end that is disposed outside of the body and manipulated manually by a clinician or automatically through, for example, robotic controls.

FIG. 9 is an isometric view of an unfinished third embodiment of the medical device, designated device 26 c (shown finished in FIG. 12c ), at a stage of construction equivalent to that shown in FIG. 7. Rather than by using longitudinally-extending element 46 in the manufacturing process to provide a wire path or conduit, as described above, device 26 c is constructed by winding one or more wires 50 directly on braid layer 44 and coupling one or more wires 50 to sensor 24 ₁. In FIG. 9, one or more wires 50 may comprise a twisted-pair cable, which may be, as shown, wound helically about braid layer 44. It should be understood that variations are possible, and that other wiring configurations (e.g., those described above) may be used.

FIG. 10 is a cross-sectional view of device 26 before reflow, taken substantially along line 10-10 in FIG. 8 (or taken at a point just proximal of sensor 24 ₁ in FIG. 9). Inner liner 42 is wrapped around mandrel 36, and braid layer 44 is wrapped around inner liner 42. Although a radial clearance is shown between inner liner 42 and braid layer 44, braid layer 44 may also be disposed tightly on inner liner 42. Additionally, because braid layer 44 is flexible and braided, the size of any radial clearance between inner liner 42 and braid layer 44 may vary over the length of device 26 and may be circumferentially asymmetrical. Longitudinally-extending element 46 is disposed “on top of” (i.e. radially outward from) braid layer 44, and outer layer 48 encompasses the assembly. Further, element 46 extends generally parallel to the main, central axis of the device 26 (see axis “A” in FIGS. 8 and 9). It should be noted that although FIG. 10 is a cross-section of the assembly in FIG. 8, which illustrates the first and second embodiments of device 26, FIG. 10 also illustrates the third embodiment, device 26 c, as indicated above.

FIG. 11 is the cross-sectional view of FIG. 10 after a reflow lamination process. Outer layer 48 has flowed into the rest of the assembly and fused to form jacket 48, embedding longitudinally-extending element 46 and braid layer 44 and filling space between longitudinally-extending element 46 and braid layer 44. Outer layer 48 has also flowed through braid layer 44 into any clearance between braid layer 44 and inner liner 42. Inner liner 42 and/or mandrel 36 are impervious to the flow of outer layer 48, so jacket 48 remains radially outward from inner liner 42. As a result, when mandrel 36 is removed after the reflow process, a central lumen 52 remains. Like FIG. 10, FIG. 11 also illustrates the third embodiment—device 26 c—by replacing longitudinally-extending element 46 with one or more wires 50.

FIGS. 12a, 12b, and 12c are expanded views of the three embodiments 26 a, 26 b, and 26 c described above. In particular, FIG. 12c shows a portion of the third embodiment of FIG. 11, indicated by circle 12.

FIG. 12a illustrates device 26 a, in which longitudinally-extending element 46 is a tube 54. Tube 54 is embedded in jacket 48, radially outward from braid layer 44. In an exemplary embodiment, tube 54 is embedded such that it is completely covered circumferentially by jacket 48, and is completely covered along its axial length by jacket 48. One or more wires 50 are provided to extend longitudinally (i.e., substantially parallel with axis “A”) through tube 54 to sensor 24 ₁ and may be coupled to sensor 24 ₁. In this regard, note that the removable stop, if used, must be removed from the distal end of tube 54, and free ends 45 ₁, 45 ₂ of coil sensor 24 ₁ are electrically connected to wiring 50 (e.g., TP cable). The wiring 50/sensor 24 ₁ connection is then embedded in the surface of outer layer 48 and is otherwise suitably finished. Tube 54 may comprise polyimide or another material able to withstand the temperatures required for the reflow process without substantially deforming (i.e. a material with a higher melting point than the material used for jacket 48). In one embodiment, tube 54 may have an inner diameter of about 0.006 inches, or about 150 micrometers—an outer diameter of about 0.008 inches, or about 200 micrometers, and a wall thickness of about 0.001-0.002 inches, or about 25-50 micrometers, though the dimensions of tube 54 may change as needed for a particular device or application.

FIG. 12b illustrates device 26 b. In the second embodiment, longitudinally-extending element 46 is a pin or other elongate member, which may be coated with PTFE or another lubricant configured to facilitate removal of the pin (or member) after reflow. The pin is removed from jacket 48 after the reflow process, preferably taken or drawn from proximal end 40 of the device. A longitudinally-extending (i.e., substantially parallel with axis “A”) wiring lumen 56 remains in jacket 48 after the pin is removed, through which one or more wires 50 may be provided for coupling to sensor 24 ₁. As in device 26 a, free ends 45 ₁, 45 ₂ of coil sensor 24 ₁ in device 26 b are electrically connected to wiring 50 (e.g., TP cable). The wiring 50/sensor 24 ₁ connection is then embedded in the surface of outer layer 48 and is otherwise suitably finished. The inner wall of wiring lumen 56 comprises the material of jacket 48.

FIG. 12c illustrates device 26 c, previously shown in FIG. 9. One or more wires 50 are embedded directly in jacket 48, having been wrapped directly on braid layer 44. It should be understood that the free ends of wiring 50 at the proximal end (not shown in FIG. 9) of device 26 c will remain free during the reflow process, and steps are taken to ensure that such free ends are not embedded in outer layer 48.

The method of manufacturing medical device 26 described in connection with FIGS. 3-12 provides many benefits. Because sensor 24 ₁, braid layer 44, and one or more wires 50 are embedded in jacket 48, device 26 has a smooth exterior with a relatively constant outer diameter. A constant and uniform outer diameter advantageously allows device 26 to be advanced and withdrawn through other devices, such as an introducer for example, and likewise have other devices extend and be advanced and withdrawn over device 26. In addition, further exterior layers may be added to device 26. Embedding one or more wires 50 in jacket 48 minimizes the effect of one or more wires 50 on the mechanical properties of device 26 and minimizes the stress induced on wiring 50 by bending of the medical device. Additionally, because device 26 is manufactured using a mandrel, as described above, device 26 may be easily fabricated to have a central lumen for the passage of materials, fluids and other devices, as known in the art.

Device 26 may also be manufactured through an alternate second method. In the second method, the sub-assembly comprising mandrel 36, inner liner 42, braid layer 44, sensor 24 ₁, and longitudinally-extending element 46 is dipped in a polymer dip solution. After the assembly is dipped, the polymer dip layer is cured, thereby encapsulating the sub-assembly. Outer layer 48 may then be added and reflow may be performed to finish device 26. The alternate method of manufacture may more reliably fill voids in the sub-assembly, but has the most benefit in those applications where a decreasing durometer shaft along the device's longitudinal length towards the distal end is not desired or required, since the dip process results in a more uniform durometer shaft (outer body or layer) as a function of the device's length.

FIG. 13 is an isometric view of a fourth embodiment of an MPS-enabled elongate medical device, designated device 26 d. Inner liner 42 and braid layer 44 are substantially the same as in the first three embodiments, devices 26 a, 26 b and 26 c. Jacket 48 has been altered relative to the other three embodiments to have an outer surface 58 with a circumferentially-extending sensor groove 60 and a longitudinally-extending wire groove 62. Sensor 24 ₁ is disposed in sensor groove 60, and one or more wires 50 are disposed in wire groove 62. Wiring 50 is electrically coupled to sensor 24 ₁. In FIG. 13, sensor 24 ₁ is a coil sensor. Sensor groove 60, and therefore sensor 24 ₁, may be placed on any part of device 26 d where a P&O may be desired or required for purposes known in the art (e.g., navigation or mapping).

Device 26 d may be manufactured by a method similar to the method used for the first three embodiments—devices 26 a, 26 b and 26 c. Inner liner 42, braid layer 44, and outer layer 48 may all be placed on a mandrel and subjected to a reflow process. Sensor groove 60 and wire groove 62 may be formed in outer surface 58 before reflow, then outer layer 48 may be prevented from flowing back into the grooves. Sensor 24 ₁ and one or more wires 50 may be added to sensor groove 60 and wire groove 62, respectively, after reflow. Sensor 24 ₁ and one or more wires 50 may then be fixed in place by applying, for example, but without limitation, adhesive, silicone coating, a heat shrink layer, or another appropriate fixation means.

FIG. 14 is a cross-sectional view of device 26 d, taken substantially along line 14-14 in FIG. 13. The radial depth of wire groove 62 is greater than the radial depth of sensor groove 60; thus, one or more wires 50 may pass underneath sensor 24 ₁ or be coupled to the underside of sensor 24 ₁. In other words, one or more wires 50 may be radially inward from at least a portion of sensor 24 ₁, for extension past sensor 24 ₁ and/or for coupling with sensor 24 ₁.

FIG. 15 is a diagrammatic view of a fifth embodiment of an MPS-enabled elongate medical device, designated device 26 e. Device 26 e may comprise a variety of medical devices, such as a catheter or an introducer. Device 26 e has a body portion 64 with a proximal end portion 66 and a distal end portion 68, two coil sensors 24 ₁, 24 ₂, and wiring 50 ₁, 50 ₂, and 50 ₃. Wiring 50 ₁, 50 ₂, and 50 ₃ may comprise, for example, twisted pair (TP) cable, as described herein. Wiring 50 ₁ and intermediate wiring piece 50 ₃ provide electrical connectivity between the proximal end of device 26 e and sensor 24 ₁. Wiring 50 ₂ provides electrical connectivity between the proximal end of device 26 e and sensor 24 ₂. Wiring 50 ₁, 50 ₂, may be incorporated into device 26 e according to one of the previous embodiments described herein. Each of the wiring 50 ₁, 50 ₂, portions extend to the proximal end of the device 26 e for connection to a connector or the like. As described elsewhere herein, such a connector may be coupled to MPS 20, where the respective signals detected by coils 24 ₁, 24 ₂, (respectively carried by wiring 50 ₁, 50 ₂, portions) may be processed by MPS 20 to determine respective position and orientation parameters associated with coils 24 ₁, 24 ₂.

Device 26 e further includes three flexible circuits 70 for routing electrical signals. Flex circuits 70 ₁ and 70 ₃ each comprise an electrically-insulative substrate 72 and one or more electrically-conductive traces 74. Each trace 74 includes a relatively large contact pad at both its distal end and its proximal end. Referring to circuit 70 ₁, leads from coil sensor 24 ₁ (i.e., free ends of the wire wound to form the coil) are electrically coupled (e.g., by soldering) to the respective distal contact pads of traces 74 ₁, 74 ₂. Leads from the distal end of intermediate wiring segment 50 ₃ are electrically coupled to the respective proximal contact pads of traces 74 ₁, 74 ₂ on flex circuit 70 ₁. As a result, flex circuit 70 ₁ provides electrical connectivity between sensor 24 ₁ and intermediate wiring segment 50 ₃.

Similarly, flex circuit 70 ₃ provides electrical connectivity between wiring 50 ₁ and wiring 50 ₃. Leads from wiring 50 ₁ are electrically coupled to respective proximal contact pads of traces 74 ₁, 74 ₂ on circuit 70 ₃. Leads from wiring 50 ₃ are electrically coupled to respective distal contact pads of traces 74 ₁, 74 ₂ on circuit 70 ₃. Flex circuit 70 ₃ is disposed radially-inwardly from sensor 24 ₂, so flex circuit 70 ₃ acts as an “electrical underpass” for routing an electrical signal detected by the sensor 24 ₁ from the distal side of sensor 24 ₂ (intermediate wiring 50 ₃) to the proximal side of sensor 24 ₂ (wiring 50 ₁).

Flex circuit 70 ₂ provides electrical connectivity between wiring 50 ₂ and sensor 24 ₂. Flex circuit 70 ₂, like 70 ₁ and 70 ₃, includes an electrically-insulative substrate 72 and a plurality of traces 74.

In the manufacturing process, flex circuits 70 may be bonded to body portion 64 before the addition of coil sensors 24. Flex circuits 70 are significantly thinner than wiring 50, so routing the signal detected by sensor 24 ₁ through the flex circuit 70 ₃ (and under sensor 24 ₂) results in less radial bulk than simply disposing a segment of wiring 50 radially-inwardly of sensor 24 ₂. Therefore, flex circuits 70 provide a means to incorporate two or more sensors on device 26 e without appreciably increasing the radial thickness of device 26 e as compared to a single-sensor device.

In another embodiment of device 26 e, wiring 50 ₃, flex pad 70 ₁, and flex pad 70 ₃ can be combined into a single longer flex circuit, minimizing cable lead exposure and termination procedures during manufacturing. In another embodiment, flex circuit 70 ₂ may be combined with flex circuit 70 ₃ to form a flex circuit with a substrate 72, four total traces 74, six contact pads on the proximal side of sensor 24 ₂ (two for wiring 50 ₁, two for wiring 50 ₂, and two for sensor 24 ₂), and two contact pads on the distal side of sensor 24 ₂. In yet a further embodiment, flex circuits 70 ₁, 70 ₂, and 70 ₃ and wiring 50 ₃ may all be combined into a single flex circuit.

FIG. 16 is a schematic and block diagram of one exemplary embodiment of MPS 20, designated as an MPS 108, as also seen by reference to U.S. Pat. No. 7,386,339, referred to above, and portions of which are reproduced below, which generally describes, at least in part, the gMPS™ medical positioning system commercially offered by MediGuide Ltd. of Haifa, Israel and now owned by St. Jude Medical, Inc. It should be understood that variations are possible, for example, as also seen by reference to U.S. Pat. No. 6,233,476 entitled MEDICAL POSITIONING SYSTEM, also hereby incorporated by reference in its entirety. Another exemplary magnetic field-based MPS is the Carto™ system commercially available from Biosense Webster, and as generally shown and described in, for example, U.S. Pat. No. 6,498,944 entitled “Intrabody Measurement,” and U.S. Pat. No. 6,788,967 entitled “Medical Diagnosis, Treatment and Imaging Systems,” both of which are incorporated herein by reference in their entireties. Accordingly, the following description is exemplary only and not limiting in nature.

MPS system 110 includes a location and orientation processor 150, a transmitter interface 152, a plurality of look-up table units 154 ₁, 154 ₂ and 154 ₃, a plurality of digital to analog converters (DAC) 156 ₁, 156 ₂ and 156 ₃, an amplifier 158, a transmitter 160, a plurality of MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N), a plurality of analog to digital converters (ADC) 164 ₁, 164 ₂, 164 ₃ and 164 _(N) and a sensor interface 166.

Transmitter interface 152 is connected to location and orientation processor 150 and to look-up table units 154 ₁, 154 ₂ and 154 ₃. DAC units 156 ₁, 156 ₂ and 156 ₃ are connected to a respective one of look-up table units 154 ₁, 154 ₂ and 154 ₃ and to amplifier 158. Amplifier 158 is further connected to transmitter 160. Transmitter 160 is also marked TX. MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N) are further marked RX₁, RX₂, RX₃ and RX_(N), respectively. Analog to digital converters (ADC) 164 ₁, 164 ₂, 164 ₃ and 164 _(N) are respectively connected to sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N) and to sensor interface 166. Sensor interface 166 is further connected to location and orientation processor 150.

Each of look-up table units 154 ₁, 154 ₂ and 154 ₃ produces a cyclic sequence of numbers and provides it to the respective DAC unit 156 ₁, 156 ₂ and 156 ₃, which in turn translates it to a respective analog signal. Each of the analog signals is respective of a different spatial axis. In the present example, look-up table 154 ₁ and DAC unit 156 ₁ produce a signal for the X axis, look-up table 154 ₂ and DAC unit 156 ₂ produce a signal for the Y axis and look-up table 154 ₃ and DAC unit 156 ₃ produce a signal for the Z axis.

DAC units 156 ₁, 156 ₂ and 156 ₃ provide their respective analog signals to amplifier 158, which amplifies and provides the amplified signals to transmitter 160. Transmitter 160 provides a multiple axis electromagnetic field, which can be detected by MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N). Each of MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N) detects an electromagnetic field, produces a respective electrical analog signal and provides it to the respective ADC unit 164 ₁, 164 ₂, 164 ₃ and 164 _(N) connected thereto. Each of the ADC units 164 ₁, 164 ₂, 164 ₃ and 164 _(N) digitizes the analog signal fed thereto, converts it to a sequence of numbers and provides it to sensor interface 166, which in turn provides it to location and orientation processor 150. Location and orientation processor 150 analyzes the received sequences of numbers, thereby determining the location and orientation of each of the MPS sensors 162 ₁, 162 ₂, 162 ₃ and 162 _(N). Location and orientation processor 150 further determines distortion events and updates look-up tables 154 ₁, 154 ₂ and 154 ₃, accordingly.

It should be understood that system 10, particularly main control 12, as described above may include conventional processing apparatus known in the art, capable of executing pre-programmed instructions stored in an associated memory, all performing in accordance with the functionality described herein. It is contemplated that the methods described herein, including without limitation the method steps of embodiments of the invention, will be programmed in a preferred embodiment, with the resulting software being stored in an associated memory and where so described, may also constitute the means for performing such methods. Implementation of the invention, in software, in view of the foregoing enabling description, would require no more than routine application of programming skills by one of ordinary skill in the art. Such a system may further be of the type having both ROM, RAM, a combination of non-volatile and volatile (modifiable) memory so that the software can be stored and yet allow storage and processing of dynamically produced data and/or signals.

Although numerous embodiments of this invention have been described above with a certain degree of particularity, those skilled in the art could make numerous alterations to the disclosed embodiments without departing from the spirit or scope of this invention. All directional references (e.g., plus, minus, upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present invention, and do not create limitations, particularly as to the position, orientation, or use of the invention. Joinder references (e.g., attached, coupled, connected, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, joinder references do not necessarily infer that two elements are directly connected and in fixed relation to each other. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the invention as defined in the appended claims. 

What is claimed is:
 1. A method of fabricating an elongate medical device having a longitudinal axis, comprising: providing an elongate liner having a distal end and a proximal end; surrounding said liner with a braid comprising metal; placing a positioning sensor over said braid at said distal end; disposing a longitudinally-extending element radially outward from said braid; applying an outer layer over said braid, said sensor, and said longitudinally-extending element; subjecting said device to a reflow lamination process; removing said longitudinally-extending element from said device to create a lumen; providing an electrically-conductive wire in said lumen; and electrically coupling said wire to said sensor.
 2. The method of claim 1, wherein said longitudinally-extending element is coated with polytetrafluoroethylene (PTFE).
 3. The method of claim 1, wherein said elongate liner is provided on a mandrel.
 4. The method of claim 1, wherein said longitudinally-extending element comprises a material that has a first melting point that is higher than a second melting point of said outer layer.
 5. The method of claim 1, wherein said lumen is parallel with said longitudinal axis.
 6. A method of fabricating an elongate medical device having a longitudinal axis, comprising: providing an elongate liner having a distal end and a proximal end; surrounding said liner with a braid comprising metal; placing a sensor over said braid at said distal end; disposing a wire radially outward from said braid so that said wire extends helically around said braid and around said longitudinal axis; applying an outer layer over said braid, said sensor, and said wire; and subjecting said device to a reflow lamination process.
 7. The method of claim 6, wherein said disposing said wire radially outward from said braid comprises disposing said wire directly on said braid.
 8. The method of claim 7, wherein said wire comprises a shielded twisted pair cable.
 9. The method of claim 6, wherein said wire comprises one of: a shielded twisted pair cable; and an unshielded twisted pair cable. 